DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Effective Responses to FDA-483 Forms and Warning Letters on Quality Systems" conference to their offering.
FDA has increasingly issued FDA-483 Observations and then turned to Warning Letters as a tool for voluntary compliance. Unfortunately, the types of issues FDA is including in FDA-483's and Warning Letters makes mere compliance not sufficient, but rather the company must have state of the art quality systems. It is no longer sufficient to have a procedure and follow it. FDA may consider the procedure inadequate and evidence you follow the procedure may not be acceptable to FDA as you may have not done it up to the FDA requirements. Effective responses to FDA-483 Observations can prevent a Warning Letter, and effective responses to Warning Letters can prevent the famous Sign or Sue Letter from FDA (the infamous consent decree).
In this seminar, we will discuss the kinds of issues FDA is citing on FDA-483's and in Warning Letters relating to quality system deficiencies. We will discuss inadequate responses and the FDA consequences for such. We will discuss how to prepare a response FDA will consider acceptable and prevent further FDA actions.
Finally, we will discuss how to establish quality systems that will be acceptable to FDA and avoid FDA-483's and Warning Letters.
Your instructor has held almost every field position within FDA during his 21-year career with FDA, Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years experience in the Medical Device industry rising from an RA Manager to being a Vice President of RA/QA/Clinical for major class 3 device manufacturers.
- Become familiar with issues that are in FDA-483's and Warning Letters
- Know what kinds of response will not be acceptable to FDA
- Know how to effectively respond to an FDA-483 or Warning Letter
- Know what kinds of company actions can avoid Warning Letters
- Know how to negotiate with FDA to effectively close Warning Letters
For more information about this conference visit http://www.researchandmarkets.com/research/6gnxvq/effective